MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOGRAFT POLYESTER VASCULAR GRAFT; VASCULAR PROSTHESIS

Catalog Number	AMC3008
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During axillary artery cannulation, albograft leaked about 3-4 cm from the site of anastomosis.The graft was about 30 cm in length.Surgeon cut the graft and used about 15 cm of the graft for implantation.During implantation, he noticed blood leaking from the proximal part of the graft.So, he removed the graft and implanted another graft.The procedure completed successfully.The implanted graft has been discarded while the non-implanted portion will be sent to us for evaluation.We have not received the graft yet.A follow-up report will be provided once we evaluate the device.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.We have not received any other complaints of similar nature for devices from this lot.Device discarded by the hospital.
Event or Problem Description
Albograft leaked around 3-4 cm from the site of anastomosis after implantation.

• Brand Name: ALBOGRAFT POLYESTER VASCULAR GRAFT
• Common Device Name: VASCULAR PROSTHESIS
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 6341099
• Report Number: 1220948-2017-00012
• Device Sequence Number: 853321
• Product Code: MAL
• UDI-Device Identifier: 00840663105304
• UDI-Public: 00840663105304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: AMC3008
• Device Lot Number: 134651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention